Replies to post #188364 on Biotech Values

[GrthzGd]

Biosimilars patent dance:

“They don't want to have to disclose their application and the information on their manufacturing process,” he says. “You're giving the enemy all the secrets to your business.”

This recalls the DC Circuit's strange, 2012 decision in Momenta/Sandoz vs. Amphastar, where the latter argued successfully that Momenta's disclosure of its manufacturing processes as part of its FDA application were, even though patent protected, fair game under Hatch Waxman. Here the disclosure requirement is directed at the challenger, but I can easily see why no sane generic maker would want to comply with the BPCIA disclosure requirements either.

[DewDiligence]

JNJ seeks to block HSP/Celltrion Remicade FoB, using essentially the same argument that AGMN is using against NVS re Zarzio:

http://www.biocentury.com/DailyNews/CurrentIssue#52299

[DewDiligence]

Apropos to NVS’ Enbrel FoB—(from your post):

Sandoz's alleged refusal to hand over its filgrastim application isn't the company's first attempt to bypass the patent dance. In 2013 the company filed a lawsuit against Amgen and Hoffman-LaRoche over another drug, a generic version of Amgen's Enbrel (etanercept).

Although Sandoz hadn't yet filed an application with the FDA and was still testing its version of etanercept in a phase 3 trial, the company asked the California Northern District Court to issue a declaratory judgment that its biosimilar will not infringe on two of Amgen's patents, and that those patents were invalid and unenforceable, in part, because they had been issued more than a decade and a half after they were first filed.

In November 2013, the judge dismissed the case as premature as Sandoz had not yet engaged in the BPCIA's patent information exchange process.

The Court may now consider this case ripe for adjudication.